PlainRecalls
FDA Devices Moderate Class II Ongoing

Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

Reported: October 16, 2024 Initiated: August 28, 2024 #Z-0053-2025

Product Description

Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket

Reason for Recall

CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.

Details

Units Affected
72 kits
Distribution
US Nationwide distribution in the state of CA.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 72 kits.
Why was this product recalled?
CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0053-2025.